Evidence map›Paper›PMID 30992081›Full record

ArticleTrials2019

Zinc in Preventing the Progression of pre-Diabetes (ZIPPeD Study) - study protocol for a randomised placebo-controlled trial in Australia.

Roseanne Peel, Alexis Hure, John Wiggers, Mark McEvoy, Elizabeth Holliday, Andrew Searles, Penny Reeves, Priyanga Ranasinghe, Ranil Jayawardena, Samir Samman and 4 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 28% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 15 citations in OpenAlex.

  1. Review
  2. Article
  3. The Role of Mitochondrial Abnormalities in Diabetic Cardiomyopathy.International journal of molecular sciences · 2022
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 6 institutions in 2 countries.

Roseanne PeelSchool of Medicine and Public Health, The University of Newcastle, Callaghan, NSW, Australia.ORCID http://orcid.org/0000-0001-9912-3198
Alexis HureSchool of Medicine and Public Health, The University of Newcastle, Callaghan, NSW, Australia.
John WiggersSchool of Medicine and Public Health, The University of Newcastle, Callaghan, NSW, Australia.
Mark McEvoySchool of Medicine and Public Health, The University of Newcastle, Callaghan, NSW, Australia.
Elizabeth HollidaySchool of Medicine and Public Health, The University of Newcastle, Callaghan, NSW, Australia.
Andrew SearlesSchool of Medicine and Public Health, The University of Newcastle, Callaghan, NSW, Australia.
Penny ReevesSchool of Medicine and Public Health, The University of Newcastle, Callaghan, NSW, Australia.
Priyanga RanasingheDepartment of Pharmacology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
Ranil JayawardenaDepartment of Pharmacology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
Samir SammanSchool of Life and Environmental Sciences, University of Sydney, Sydney, NSW, Australia.
Shamasunder AcharyaDivision of Medicine, Hunter New England Local Health District, New Lambton, NSW, Australia.
Judy LuuDivision of Medicine, Hunter New England Local Health District, New Lambton, NSW, Australia.
Chris RisselThe NSW Office of Preventive Health, South Western Sydney Local Health District, Liverpool Hospital, Liverpool, NSW, Australia.
John AttiaSchool of Medicine and Public Health, The University of Newcastle, Callaghan, NSW, Australia. john.attia@newcastle.edu.au.
Hunter New England Local Health District · AUUniversity of Newcastle Australia · AUHunter Medical Research Institute · AUUniversity of Colombo · LKLiverpool Hospital · AUThe University of Sydney · AU

Funding

NSW Ministry of Health H18/31636
6 · The paper itself

Abstract

backgroundDiabetes is increasing in incidence, morbidity and treatment costs globally, hence prevention strategies need to be explored. Animal studies and some human data have shown that zinc can improve glycaemic control, but the impact of this effect in a pre-diabetic population remains uncertain. This study is designed to investigate whether zinc gluconate and lifestyle coaching can improve glucose handling and ultimately reduce diabetes incidence in an at-risk pre-diabetic population in Australia. METHODS/

designThe study will be a randomised, placebo-controlled, double-blind clinical trial. The study will be conducted at the Hunter New England Local Health District New South Wales (NSW), Australia. Pre-diabetic (haemoglobin A1c [HbA1c] 5.7-6.4) male and female participants (n = 410) aged 40-70 years will be recruited through the Diabetes Alliance Network, a collaboration of diabetes specialists and general practitioner practices. All participants will be given routine care to encourage healthy lifestyle changes using a telephone coaching service (Get Healthy Information and Coaching Service, NSW Health) and then randomised to receive a supplement, either zinc gluconate (equivalent to 30 mg of elemental zinc) or placebo of identical appearance for 12 months. The identity of the supplements will be blinded to both research personnel and the participants. Participants will be asked to complete medical, lifestyle and dietary surveys and will have baseline and final visits at their general practitioner practice. Primary outcomes will be HbA1c and insulin sensitivity collected at baseline and at 1, 6 and 12 months; secondary outcomes will include fasting blood glucose, fasting cholesterol, blood pressure and body mass index. The primary efficacy endpoint will be judged at 6 months. DISCUSSION: This study will generate new evidence about the potential for health coaching, with or without zinc supplementation, to improve glucose handling and ultimately to reduce progression from pre-diabetes to diabetes.

trial registrationAustralian and New Zealand Clinical Trials Registry, ACTRN12618001120268 . Registered on 6 July 2018.

Indexed as

Randomized Controlled Trials as TopicAdultAgedDiabetes Mellitus, Type 2Dietary SupplementsDisease ProgressionDouble-Blind MethodFemaleGlycated HemoglobinHumansMaleMiddle AgedOutcome Assessment, Health CarePrediabetic StateZincGlycated Hemoglobinhemoglobin A1c protein, humanZincAdultsAustraliaHealthy lifestylePre-diabetesZinc supplementation

Identifiers

PMID30992081
PMCPMC6466783
OpenAlexW2947973046

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.